Delivery devices and methods for leadless cardiac devices

ABSTRACT

Delivery devices, systems, and methods for delivering implantable leadless pacing devices are disclosed. An example delivery device may an outer tubular member and an inner tubular member slidably disposed within the lumen of the outer tubular member. A distal holding section may extend distally of a distal end of the inner tubular member and define a cavity therein for receiving an implantable leadless pacing device. The device may further include a hub portion including at least a first hub portion affixed adjacent to the proximal end of the outer tubular member and a second hub portion affixed adjacent to the proximal end of the inner tubular member. A first locking mechanism configured to releasably couple the outer tubular member and the inner tubular member may be disposed within the hub portion.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/935,611, filed Mar. 26, 2018, which is a continuation of U.S.application Ser. No. 14/919,310, filed Oct. 21, 2015, now U.S. Pat. No.9,956,400, which claims priority under 35 U.S.C. § 119 to U.S.Provisional Application Ser. No. 62/067,140, filed Oct. 22, 2014, theentirety of which are incorporated herein by reference.

TECHNICAL FIELD

The present disclosure pertains to medical devices, and methods formanufacturing and/or using medical devices. More particularly, thepresent disclosure pertains to leadless cardiac devices and methods,such as leadless pacing devices and methods, and delivery devices andmethods for such leadless devices.

BACKGROUND

A wide variety of medical devices have been developed for medical use,for example, cardiac use. Some of these devices include catheters,leads, pacemakers, and the like, and delivery devices and/or systemsused for delivering such devices. These devices are manufactured by anyone of a variety of different manufacturing methods and may be usedaccording to any one of a variety of methods. Of the known medicaldevices, delivery systems, and methods, each has certain advantages anddisadvantages. There is an ongoing need to provide alternative medicaldevices and delivery devices as well as alternative methods formanufacturing and using medical devices and delivery devices.

BRIEF SUMMARY

This disclosure provides design, material, manufacturing method, and usealternatives for medical devices, including delivery devices.

In a first example, a delivery device for delivering an implantableleadless pacing device may comprise an outer tubular member including alumen extending from a proximal end to a distal end thereof, an innertubular member including a lumen extending from a proximal end to adistal end thereof, the inner tubular member slidably disposed withinthe lumen of the outer tubular member, a distal holding sectionextending distally of a distal end of the inner tubular member, thedistal holding section defining a cavity therein for receiving animplantable leadless pacing device, a handle assembly including at leasta first hub portion affixed adjacent to the proximal end of the outertubular member and intermediate second hub portion affixed adjacent tothe proximal end of the inner tubular member, and a first lockingmechanism disposed within the handle assembly, wherein the first lockingmechanism is configured to releasably couple the first hub portion andthe second hub portion.

Alternatively or additionally to any of the examples above, in anotherexample, the first locking mechanism may have a locked position and anunlocked position wherein the inner tubular member is held in tension inthe locked position.

Alternatively or additionally to any of the examples above, in anotherexample, the outer tubular member may be held in compression in thelocked position.

Alternatively or additionally to any of the examples above, in anotherexample, the first hub portion and the second hub portion may beindividually slidable and rotatable when the first locking mechanism isin an unlocked configuration.

Alternatively or additionally to any of the examples above, in anotherexample, the first locking mechanism may be selected from the group of asnap lock, a threaded engagement, or a quick connect locking feature.

Alternatively or additionally to any of the examples above, in anotherexample, the first locking mechanism may comprise a bayonet stylelocking mechanism.

Alternatively or additionally to any of the examples above, in anotherexample, the second hub portion may comprise a groove positionedadjacent a distal end of the second hub portion, the groove configuredto receive an inwardly extending protrusion of the first hub portion.

Alternatively or additionally to any of the examples above, in anotherexample, the groove may comprise a first portion, a second portionextending generally orthogonal to the first portion, and a serifpositioned at an end of the second portion.

Alternatively or additionally to any of the examples above, in anotherexample, disposing the protrusion within the serif may releasably couplethe outer tubular member and the inner tubular member such thatlongitudinal or rotational actuation of either of the outer tubularmember or the inner tubular member results in corresponding actuation ofboth the outer tubular member and the inner tubular member.

Alternatively or additionally to any of the examples above, in anotherexample, disposing the protrusion within the serif may place the innertubular member in tension and the outer tubular member in compression.

Alternatively or additionally to any of the examples above, in anotherexample, the device may further comprise a push member slidably disposedwithin the lumen of the inner tubular member.

Alternatively or additionally to any of the examples above, in anotherexample, the device may further comprise a third hub portion affixedadjacent to a proximal end of the push member.

Alternatively or additionally to any of the examples above, in anotherexample, the device may further comprise a second locking mechanismdisposed within the handle assembly.

Alternatively or additionally to any of the examples above, in anotherexample, the third hub portion may be slidable and rotatable independentof either of the first hub portion or the second hub portion when thesecond locking mechanism is in an unlocked configuration.

Alternatively or additionally to any of the examples above, in anotherexample, longitudinal or rotational actuation of either of the innertubular member or the push member may result in corresponding actuationof both the inner tubular member and the push member when the secondlocking mechanism is in a locked configuration.

Alternatively or additionally to any of the examples above, in anotherexample, a method of releasably coupling an outer tubular member affixedto a first hub portion to an inner tubular member affixed to a secondhub portion of a delivery device may comprise rotating the second hubportion relative to the first hub portion, the first hub portion havingan inwardly extending protrusion, to align the protrusion with a firstportion of a groove on a distal portion of the second hub portion,proximally retracting the second hub portion to advance the protrusioninto the first portion of the groove, rotating the second hub portionrelative to the first hub portion about a longitudinal axis of the firsthub portion to advance the protrusion along a second portion of thegroove, the second portion of the groove extending generally orthogonalto the first portion of the groove, and disposing the protrusion withina serif positioned at an end of the second portion of the groove.

Alternatively or additionally to any of the examples above, in anotherexample, a delivery device for delivering an implantable leadless pacingdevice may comprise an outer tubular member including a lumen extendingfrom a proximal end to a distal end thereof, an inner tubular memberincluding a lumen extending from a proximal end to a distal end thereof,the inner tubular member slidably disposed within the lumen of the outertubular member, a distal holding section extending distally of a distalend of the inner tubular member, the distal holding section defining acavity therein for receiving an implantable leadless pacing device, ahandle assembly including at least a first hub portion affixed adjacentto the proximal end of the outer tubular member and a second hub portionaffixed adjacent to the proximal end of the inner tubular member, and afirst locking mechanism disposed within the handle assembly, wherein thefirst locking mechanism is configured to releasably couple the first hubportion and the second hub portion.

Alternatively or additionally to any of the examples above, in anotherexample, the first locking mechanism may have a locked position and anunlocked position wherein the inner tubular member is held in tension inthe locked position.

Alternatively or additionally to any of the examples above, in anotherexample, the outer tubular member may be held in compression in thelocked position.

Alternatively or additionally to any of the examples above, in anotherexample, the first hub portion and the second hub portion may beindividually slidable and rotatable when the first locking mechanism isin an unlocked configuration.

Alternatively or additionally to any of the examples above, in anotherexample, the first locking mechanism may comprise a bayonet stylelocking mechanism.

Alternatively or additionally to any of the examples above, in anotherexample, the second hub portion may comprise a groove positionedadjacent a distal end of the second hub portion, the groove configuredto receive an inwardly extending protrusion of the first hub portion.

Alternatively or additionally to any of the examples above, in anotherexample, the groove may comprise a first portion, a second portionextending generally orthogonal to the first portion, and a serifpositioned at an end of the second portion.

Alternatively or additionally to any of the examples above, in anotherexample, disposing the protrusion within the serif may releasably couplethe outer tubular member and the inner tubular member such thatlongitudinal or rotational actuation of either of the outer tubularmember or the inner tubular member results in corresponding actuation ofboth the outer tubular member and the inner tubular member.

Alternatively or additionally to any of the examples above, in anotherexample, disposing the protrusion within the serif may place the innertubular member in tension and the outer tubular member in compression.

Alternatively or additionally to any of the examples above, in anotherexample, the device may further comprise a push member slidably disposedwithin the lumen of the inner tubular member.

Alternatively or additionally to any of the examples above, in anotherexample, the device may further comprise a third hub portion affixedadjacent to a proximal end of the push member.

Alternatively or additionally to any of the examples above, in anotherexample, the device may further comprise a second locking mechanismdisposed within the handle assembly.

Alternatively or additionally to any of the examples above, in anotherexample, the third hub portion may be slidable and rotatable independentof either of the first hub portion or the second hub portion when thesecond locking mechanism is in an unlocked configuration.

Alternatively or additionally to any of the examples above, in anotherexample, the first locking mechanism may be selected from the group of asnap lock, a threaded engagement, or a quick connect locking feature.

Alternatively or additionally to any of the examples above, in anotherexample, longitudinal or rotational actuation of either of the innertubular member or the push member may result in corresponding actuationof both the inner tubular member and the push member when the secondlocking mechanism is in a locked configuration.

Alternatively or additionally to any of the examples above, in anotherexample, a delivery device for delivering an implantable leadless pacingdevice may comprise an outer tubular member including a lumen extendingfrom a proximal end to a distal end thereof, an inner tubular memberincluding a lumen extending from a proximal end to a distal end thereof,the inner tubular member slidably disposed within the lumen of the outertubular member, a push member having a proximal end and a distal end,the push member slidably disposed within the lumen of the inner tubularmember, a distal holding section extending distally of a distal end ofthe inner tubular member, the distal holding section defining a cavitytherein for receiving an implantable leadless pacing device, a handleassembly including a distal hub portion affixed adjacent to the proximalend of the outer tubular member, an intermediate hub portion affixedadjacent to the proximal end of the inner tubular member, and a proximalhub portion affixed adjacent to the proximal end of the push member, thedistal hub portion, the intermediate hub portion, and the proximal hubportion arranged in a telescoping configuration such that each of thedistal hub portion, intermediate hub portion, and proximal hub portionare capable of being longitudinally and rotationally actuatedindividually, and a first locking mechanism disposed between the distalhub portion and the intermediate hub portion, wherein the first lockingmechanism is configured to releasably couple the distal hub portion andthe intermediate hub portion.

Alternatively or additionally to any of the examples above, in anotherexample, the first locking mechanism may be user actuatable between anunlocked configuration and a locked configuration.

Alternatively or additionally to any of the examples above, in anotherexample, when in the locked configuration, the intermediate hub portionmay be proximally retracted to place the inner tubular member in tensionand the outer tubular member in compression.

Alternatively or additionally to any of the examples above, in anotherexample, a method of releasably coupling an outer tubular member affixedto a first hub portion and an inner tubular member affixed to a secondhub portion of a delivery device may comprise rotating a the first hubportion in a first direction relative to the second hub portion, thefirst hub portion having an inwardly extending protrusion, to align theprotrusion with a first portion of a groove on a distal portion of asecond hub portion, advancing the protrusion into the first portion ofthe groove, rotating the second hub portion relative to the first hubportion and about a longitudinal axis of the first hub portion in afirst direction to advance the protrusion along a second portion of thegroove, the second portion of the groove extending generally orthogonalto the first portion of the groove, and disposing the protrusion withina serif positioned at an end of the second portion of the groove.

Alternatively or additionally to any of the examples above, in anotherexample, disposing the protrusion within the serif may releasably couplethe inner tubular member and the outer tubular member such thatlongitudinal or rotational actuation of either of the outer tubularmember or the inner tubular member results in corresponding actuation ofboth the outer tubular member and the inner tubular member.

Alternatively or additionally to any of the examples above, in anotherexample, the method may further comprise disengaging the protrusion fromthe serif, rotating the second hub portion relative to the first hubportion in a second direction, the second direction generally oppositeto the first direction, to advance the protrusion along a second portionof the groove towards the first portion of the groove, and distallyadvancing the second hub portion to disengage the protrusion from thefirst portion of the groove, wherein disengaging the protrusion from thefirst portion of the groove uncouples the inner tubular member and theouter tubular member.

The above summary of some embodiments is not intended to describe eachdisclosed embodiment or every implementation of the present disclosure.The Figures, and Detailed Description, which follow, more particularlyexemplify some of these embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure may be more completely understood in consideration of thefollowing detailed description in connection with the accompanyingdrawings, in which:

FIG. 1 is a plan view of an example leadless pacing device implantedwithin a heart;

FIG. 2 is a perspective view of an example delivery device for animplantable leadless cardiac pacing device;

FIG. 3 is a partial cross-sectional side view of the distal portion ofthe delivery device of FIG. 2;

FIG. 3A is a partial cross-sectional side view of a portion of a distalportion of another illustrative delivery device;

FIG. 3B is a partial cross-sectional side view of a portion of a distalportion of another illustrative delivery device;

FIG. 3C is a partial perspective view of a portion of a distal portionof another illustrative delivery device;

FIG. 4 is a cross-sectional side view of the proximal portion of thedelivery device of FIG. 2;

FIG. 5 is a perspective view of the proximal portion of the deliverydevice of FIG. 2 with portions removed;

FIGS. 6A-6E are a schematic view of a locking mechanism of the proximalportion of the delivery device of FIG. 2; and

FIG. 7 is a perspective view of the proximal portion of the deliverydevice of FIG. 2 with portions removed.

While the disclosure is amenable to various modifications andalternative forms, specifics thereof have been shown by way of examplein the drawings and will be described in detail. It should beunderstood, however, that the intention is not to limit the invention tothe particular embodiments described. On the contrary, the intention isto cover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the disclosure.

DETAILED DESCRIPTION

For the following defined terms, these definitions shall be applied,unless a different definition is given in the claims or elsewhere inthis specification.

All numeric values are herein assumed to be modified by the term“about,” whether or not explicitly indicated. The term “about” generallyrefers to a range of numbers that one of skill in the art would considerequivalent to the recited value (i.e., having the same function orresult). In many instances, the terms “about” may include numbers thatare rounded to the nearest significant figure.

The recitation of numerical ranges by endpoints includes all numberswithin that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and5).

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” include plural referents unless the contentclearly dictates otherwise. As used in this specification and theappended claims, the term “or” is generally employed in its senseincluding “and/or” unless the content clearly dictates otherwise.

It is noted that references in the specification to “an embodiment”,“some embodiments”, “other embodiments”, etc., indicate that theembodiment described may include one or more particular features,structures, and/or characteristics. However, such recitations do notnecessarily mean that all embodiments include the particular features,structures, and/or characteristics. Additionally, when particularfeatures, structures, and/or characteristics are described in connectionwith one embodiment, it should be understood that such features,structures, and/or characteristics may also be used connection withother embodiments whether or not explicitly described unless clearlystated to the contrary.

The following detailed description should be read with reference to thedrawings in which similar structures in different drawings are numberedthe same. The drawings, which are not necessarily to scale, depictillustrative embodiments and are not intended to limit the scope of thedisclosure.

Cardiac pacemakers provide electrical stimulation to heart tissue tocause the heart to contract and thus pump blood through the vascularsystem. Conventional pacemakers typically include an electrical leadthat extends from a pulse generator implanted subcutaneously orsub-muscularly to an electrode positioned adjacent the inside or outsidewall of the cardiac chamber. As an alternative to conventionalpacemakers, self-contained or leadless cardiac pacemakers have beenproposed. Leadless cardiac pacemakers are small capsules typically fixedto an intracardiac implant site in a cardiac chamber. The small capsuletypically includes bipolar pacing/sensing electrodes, a power source(e.g. a battery), and associated electrical circuitry for controllingthe pacing/sensing electrodes, and thus provide electrical stimulationto heart tissue and/or sense a physiological condition. The capsule maybe delivery to the heart using a delivery device which may be advancedthrough a femoral vein, into the inferior vena cava, into the rightatrium, through the tricuspid valve, and into the right ventricle.Accordingly, it may be desirable to provide delivery devices whichfacilitate advancement through the vasculature.

FIG. 1 illustrates an example implantable leadless cardiac pacing device10 (e.g., a leadless pacemaker) implanted in a chamber of a heart H,such as the right ventricle RV. The implantable device 10 may include ashell or housing 12 having a proximal end 14 and a distal end 16. Theimplantable device 10 may include a first electrode 20 positionedadjacent to the distal end 16 of the housing 12 and a second electrode22 positioned adjacent to the proximal end 14 of the housing 12. Forexample, housing 12 may include a conductive material and may beinsulated along a portion of its length. A section along the proximalend 14 may be free of insulation so as to define the second electrode22. The electrodes 20, 22 may be sensing and/or pacing electrodes toprovide electro-therapy and/or sensing capabilities. The first electrode20 may be capable of being positioned against or may otherwise contactthe cardiac tissue of the heart H while the second electrode 22 may bespaced away from the first electrode 20, and thus spaced away from thecardiac tissue.

The implantable device 10 may include a pulse generator (e.g.,electrical circuitry) and a power source (e.g., a battery) within thehousing 12 to provide electrical signals to the electrodes 20, 22 andthus control the pacing/sensing electrodes 20, 22. Electricalcommunication between the pulse generator and the electrodes 20, 22 mayprovide electrical stimulation to heart tissue and/or sense aphysiological condition.

The implantable device 10 may include a fixation mechanism 24 proximatethe distal end 16 of the housing 12 configured to attach the implantabledevice 10 to a tissue wall of the heart H, or otherwise anchor theimplantable device 10 to the anatomy of the patient. As shown in FIG. 1,in some instances, the fixation mechanism 24 may include one or more, ora plurality of hooks 26 anchored into the cardiac tissue of the heart Hto attach the implantable device 10 to a tissue wall. In otherinstances, the fixation mechanism 24 may include one or more, or aplurality of passive tines, configured to entangle with trabeculaewithin the chamber of the heart H and/or a helical fixation anchorconfigured to be screwed into a tissue wall to anchor the implantabledevice 10 to the heart H.

The implantable device 10 may include a docking member 30 proximate theproximal end 14 of the housing 12 configured to facilitate deliveryand/or retrieval of the implantable device 10. For example, the dockingmember 30 may extend from the proximal end 14 of the housing 12 along alongitudinal axis of the housing 12. The docking member 30 may include ahead portion 32 and a neck portion 34 extending between the housing 12and the head portion 32. The head portion 32 may be an enlarged portionrelative to the neck portion 34. For example, the head portion 32 mayhave a radial dimension from the longitudinal axis of the implantabledevice 10 which is greater than a radial dimension of the neck portionfrom the longitudinal axis of the implantable device 10. The dockingmember 30 may be configured to facilitate delivery of the implantabledevice 10 to the intracardiac site and/or retrieval of the implantabledevice 10 from the intracardiac site. Other docking members 30 arecontemplated.

One aspect of the current disclosure relates to the delivery deviceand/or system used, for example, to deliver device 10 to a suitablelocation within the anatomy (e.g., the heart). As may be appreciated,the delivery device may need to be navigated through relatively tortuousanatomy to deliver the device 10 to a suitable location. For instance,in some embodiments, the delivery device may be advanced through thevasculature to a target region. In some example cases the device may beadvanced through a femoral vein, into the inferior vena cava, into theright atrium, through the tricuspid valve, and into the right ventricle.The target region for the delivery of the device 10 may be a portion ofthe right ventricle, for example, a portion of the right ventricle nearthe apex of the heart. The target region may also include other regionsof the heart (e.g., right atrium, left atrium, or left ventricle), bloodvessels, or other suitable targets. It may be desirable to provide thedelivery system with certain features that may allow for easier orbetter control for navigation or delivery purposes.

FIG. 2 is a perspective view of an illustrative delivery device 100,such as a catheter, that may be used to deliver the device 10. Thedelivery device 100 may include an outer tubular member 102 having aproximal section 104 and a distal section 106. An inner tubular member110 may be slidably disposed within a lumen 150 of the outer tubularmember 102 (see e.g. FIGS. 3 and 4). A distal holding section 108 may beattached to a distal end portion 114 of the inner tubular member 110.The delivery device 100 may also include a handle assembly 120positioned adjacent to the proximal section of the outer tubular member102. In some embodiments, the outer tubular member 102 may include atleast a section thereof that has an outer diameter D2 that is less thanthe outer diameter D1 of at least a portion of the holding section 108(see e.g. FIG. 3).

The handle assembly 120 may include a first or distal hub portion 126attached to the proximal end section 104 of the outer tubular member102, a second or intermediate hub portion 128 attached to a proximal endsection of the inner tubular member 110, and a third or proximal hubportion 130 attached to a proximal end section of a push member 116 (seee.g. FIG. 3). The first hub portion 126, second hub portion 128, andthird hub portion 130 may be positioned in a generally telescopingarrangement and slidable relative to each other. As will be discussed inmore detail below, each of the first hub portion 126, the second hubportion 128, and the third hub portion 130 may be slidable and rotatablerelative to each other such that the outer tubular member 102, innertubular member 110, and push member 116 may be individually actuated. Insome instances, it may be desirable to move the outer tubular member102, inner tubular member 110 and push member 116 simultaneously. Thehandle assembly 120 may include a first locking mechanism 132 toreleasably couple the outer tubular member 102 to the inner tubularmember 110, as will be discussed in more detail below. The handleassembly 120 may also include a second locking mechanism 134 toreleasably couple the inner tubular member 110 to the push member 116,as will be discussed in more detail below.

The distal holding section 108 may be configured to receive theimplantable device 10 therein. For example, referring to FIG. 3, whichillustrates a cross-sectional view of a distal portion of deliverydevice 100, the holding section 108 may define a cavity 142 for slidablyreceiving the implantable device 10, and may include a distal opening144 for slidable insertion and/or extraction of the implantable device10 into and/or out of the cavity 142.

The distal holding section 108 may include a body portion 138 and adistal tip portion 140 that may be, for example, configured to beatraumatic to anatomy, such as a bumper tip. For example, as thecatheter is navigated through the anatomy, the distal tip may come intocontact with anatomy. Additionally, when the catheter is used to deliverthe device, the tip 140 of the delivery device 100 will likely come intocontact with tissue adjacent the target cite (e.g. cardiac tissue of theheart). A hard distal tip formed of the material of the outer tubularmember 102 and/or inner tubular member 110 may injure a vessel wall orcardiac tissue. As such, it may be desirable to provide the deliverydevice 100 with a softer distal tip 140 that can be introduced into theanatomy and come into contact with anatomy adjacent the target citewithout causing unnecessary trauma.

For example, the distal tip 140 may be made of a material that is softerthan the body portion 138 of the distal holding section. In some cases,the distal tip 140 may include a material that has a durometer that isless than the durometer of the material of the body portion 138. In someparticular embodiments, the durometer of the material used in the distaltip 140 may be in the range of about 5 D to about 70 D, or for example,in the range of about 25 D to about 65 D. Additionally, the distal tip140 may include a shape or structure that may make it less traumatic totissue. For example, the distal tip 140 may have a distal surface, suchas a tissue contacting surface, that is that is rounded or includes acurvature configured to be more atraumatic to tissue.

In some embodiments, all or a portion of the distal holding section 108may include an inner surface that may be configured to resist gettingcaught on the fixation mechanism 24, such as the one or more, or aplurality of hooks 26 on the device 10. For example, the distal holdingsection 108 may include an inner layer or coating of harder or morelubricious material that resists force applied by the fixation mechanism24 onto the inner surface of the distal holding section 108. Forexample, the distal holding section 108 may include a multi-layeredstructure, and an inner layer may be made of a material that is harderthan an outer layer.

A push member 116 may be disposed (e.g., slidably disposed) within alumen 152 of the inner tubular member 110. The push member 116 may beengaged by a user near or at the third hub portion 130, and extendthrough a lumen 152 of the inner tubular member 110 and into the distalholding section 108. A distal portion 118 of the push member 116 may becapable of engaging the device 10, and the push member 116 may be usedto “push” the device 10 out from distal holding section 108 so as todeploy and anchor device 10 within a target region (e.g., a region ofthe heart such as the right ventricle).

In order to more specifically place or steer the delivery device 100 toa position adjacent to the intended target, the delivery device 100 maybe configured to be deflectable or articulable or steerable. Referringto FIG. 2, for example, the outer tubular member 102 and/or innertubular member 110 may include one or more articulation or deflectionmechanism(s) that may allow for the catheter 100, or portions thereof,to be deflected, articulated, steered and/or controlled in a desiredmanner. For example, the outer tubular member 102 may include at least aportion thereof that can be selectively bent and/or deflected in adesired or predetermined direction. This may, for example, allow a userto orient the delivery device 100 such that the holding section 108 isin a desirable position or orientation for navigation or delivery of thedevice 10 to a target location. The outer tubular member 102 may bedeflected, for example, along a deflection region.

A wide variety of deflection mechanisms may be used. In some exampleembodiments, deflection may be effected by one or more actuationmembers, such as pull wire(s) extending between a distal portion of theouter tubular member 102 and an actuation mechanism 122 near theproximal end of the outer tubular member 102. As such, the one or morepull wires may extend both proximally and distally of the desireddeflection or bending region or point. This allows a user to actuate(e.g., “pull”) one or more of the pull wires to apply a compressionand/or deflection force to at least a portion of the outer tubularmember 102 and thereby deflect or bend the outer tubular member 102 in adesired manner. In addition, in some cases the one or more wires may bestiff enough so that they can also be used to provide a pushing and/ortensioning force on the outer tubular member 102, for example, to “push”or “straighten” the shaft into a desired position or orientation.

In some embodiments, the actuation member takes the form of a continuouswire that is looped through or otherwise coupled to a distal end regionof the outer tubular member 102 so as to define a pair of wire sections.Other embodiments are contemplated, however, including embodiments wherethe actuation member includes one or a plurality of individual wiresthat are attached, for example, to a metal or metal alloy ring adjacentthe distal end region of the outer tubular member 102.

The actuation mechanism 122 may include a desired mechanism that mayallow for applying tension (i.e. pulling force), or compression (i.e.pushing force), or both, on the actuation member(s). In someembodiments, the actuation mechanism 122 may include an externalrotatable member 124 connected to and rotatable about the longitudinalaxis of the handle assembly 120. The rotatable member 124 maythreadingly engage an internal member that is attached to the proximalend of the actuation member(s) or pull wires. When the externalrotatable member 124 is rotated in a first rotational direction, theinternal member translates in a first longitudinal direction, therebyapplying tension to the pull wires, which applies compression force tothe shaft, so as to deflect the outer tubular member 102 from an initialposition to a deflected position. When the external rotatable member 124is rotated in a second rotational direction, the internal membertranslates in a second longitudinal direction, thereby releasing thetension on the pull wires, and allowing the outer tubular member 102 torelax back toward the initial position. Additionally, in some cases, asmentioned above, where the one or more wires may be stiff enough,rotation of the rotatable member 124 in the second rotational directionsuch that the internal member translates in a second longitudinaldirection may apply compression to the wires, such that the wires mayapply tension to the outer tubular member 102 and “push” the outertubular member 102 back toward an initial position, and possibly intoadditional positions beyond the initial position.

The one or more articulation and/or deflection mechanism(s) may alsoentail the outer tubular member 102 including structure and/or materialthat may provide for the desired degree and/or location of thedeflection when the compressive or tensile forces are applied. Forexample, the outer tubular member 102 may include one or more sectionsthat include structure and/or material configured to allow the shaft tobend and/or deflect in a certain way when a certain predeterminedcompressive and/or tensile force is applied. For example, the shaft mayinclude one or more sections that are more flexible than other sections,thereby defining a bending or articulating region or location. Some suchregions may include a number of varying or changing flexibilitycharacteristics that may define certain bending shapes whenpredetermined forces are applied. Such characteristics may be achievedthrough the selection of materials or structure for different sectionsof the outer tubular member 102.

In other embodiments, other articulation and/or deflection mechanism(s)are contemplated. For example, all or a portion of the delivery device100, such as the outer tubular member 102, may be made of a shape memorymaterial, such as a shape memory polymer and/or a shape memory metal.Such materials, when stimulated by an actuation mechanism, such as achange in temperature or the application of an electrical current, maychange or move from a first shape to a second shape. As such, thesematerial and mechanism may be used to deflect or bend the outer tubularmember 102 in a desired manner. Other suitable deflection mechanism(s)that are able to deflect the delivery device 100 may also be used. Suchalternative mechanisms may be applied to all other embodiments shownand/or discussed herein, and others, as appropriate.

Furthermore, the outer tubular member 102 may include one or morepredefined or fixed curved portion(s) along the length thereof. In somecases, such curved sections may be configured to fit with particularanatomies or be configured for better navigation or delivery of thedevice 10. Additionally, or alternatively, some such curved sections maybe configured to allow the outer tubular member 102 to be predisposed tobe bent and/or deflected in a certain direction or configuration whencompression and/or tension forces are applied thereto.

Returning again to FIG. 3, the distal holding section 108 may be affixedto a distal end portion 114 of the inner tubular member 110. The distalholding section 108 may include a hub portion 136 and a tubular bodyportion 138. In some instances, the hub portion 136 may be formed from ametal or metal alloy while the body portion 138 may be formed from apolymeric material, although this is not required. In some instances, aproximal region 143 of the body portion 138 may be heat bonded to adistal end portion 137 of the hub portion 136, or otherwise affixed. Asthe body portion 138 is heated, the body portion 138 may reflow intogrooves 141 in the distal end portion 137. The hub portion 136 mayinclude a tapered intermediate region 145 disposed between a proximalend portion 139 and the distal end portion 137.

In some embodiments, the outer tubular member 102 may include a metalring or tip adjacent the distal end 103 thereof for attaching one ormore pull wires thereto. It is contemplated that the outer tubularmember 102 may further include a lubricious liner, such as, but notlimited to a polytetrafluoroethylene (PTFE) liner. The proximal endportion 139 of the hub portion 136 may extend proximally into the lumen150 of the outer tubular member 102. In some instances, an outer surfaceof the proximal end portion 139 may form an interference fit with aninner surface of the outer tubular member 102. It is contemplated thatthe outer surface of the proximal end portion 139 and the inner surfaceof the outer tubular member 102 may be coupled in a tapered engagement.For example, the distal end 103 of the outer tubular member 102 mayflare radially outwards in the distal direction and/or the proximal endportion 139 may taper radially inward in the proximal direction. The twoangled surface may engage as the proximal end portion 139 is proximallyretracted within the outer tubular member 102. Other couplingarrangements may be used as desired.

FIG. 3A illustrates a partial cross-sectional view of an alternativemechanism for coupling the outer tubular member 102 a to the proximalend 139 a of the hub portion 136 a. Some components have been removedfor clarity. The outer tubular member 102 a and the hub portion 136 amay be similar in form and function to the outer tubular member 102 andthe hub portion 136 described above. In some instances, the outertubular member 102 a and the proximal end portion 139 a may be coupledthrough a threaded engagement. For example, the outer tubular member 102a may include a first helical flange or threaded portion 125 a and theproximal end portion 139 a may include a second helical flange orthreaded portion 127 a configured to mate with and/or threadably engagethe helical flange or threaded portion 125 a on the outer tubular member102 a. It is contemplated that the outer tubular member 102 a and/or thehub portion 136 a may be rotated in a first direction causing helicalflanges or threaded portions 125 a, 127 a to engage. Rotation of theouter tubular member 102 a and/or the hub portion 136 a in a seconddirection opposite the first direction may cause the helical flanges orthreaded portions 125 a, 127 a to disengage.

FIG. 3B illustrates a partial cross-sectional view of an alternativemechanism for coupling the outer tubular member 102 b to the proximalend 139 b of the hub portion 136 b. The outer tubular member 102 b andthe hub portion 136 b may be similar in form and function to the outertubular member 102 and the hub portion 136 described above. The couplingarrangement may include a snap lock, a tongue and groove type lock, amating detent and groove or other features configured to engage acorresponding feature on the outer tubular member 102 b and/or theproximal end portion 139 b. For example, the outer tubular member 102 bmay include a groove or recess 121 b disposed in an inner wall thereof.The proximal end 139 b may include a protrusion, bump, or otherextending feature 123 b configured to mate or engage with the recess 121b in the outer tubular member 102 b. It is contemplated that theprotrusion 123 b and the groove 121 b may be disengaged throughapplication of an external force (e.g., axial force) such as proximalretraction of the outer tubular member 102 b and/or distal actuation ofthe hub portion 136 b.

FIG. 3C illustrates a perspective view of another alternative mechanismfor coupling the outer tubular member 102 c to the proximal end 139 c ofthe hub portion 136 c. The outer tubular member 102 c and the hubportion 136 c may be similar in form and function to the outer tubularmember 102 and the hub portion 136 described above. In some embodiments,the outer tubular member 102 c and the proximal end portion 139 c may becoupled through a bayonet style locking feature. It is contemplated thata generally “L” shaped groove 190 c may be formed in the proximal end139 c of the hub portion 136 c. In some instances, the outer tubularmember 102 c may include a protrusion 188 c extending radially inwardfrom an inner surface of the outer tubular member 102 c. The “L” shapedgroove 190 c and the protrusion 188 c may be configured to releasablyengage one another in a manner similar the locking mechanism 132described with respect to FIGS. 6A-6E such that the outer tubular member102 c and the proximal end 139 c of the hub portion 136 c may bereleasably coupled. Alternatively, a generally “L” shaped groove may beformed in the distal end of the outer tubular member 102 c and theproximal end 139 c of the hub portion 136 c may include a protrusionextending radially outward therefrom for mating engagement with thegroove.

It is contemplated that as the outer tubular member 102 is bent tonavigate the implantable device 10 to the desired location, the proximalend portion 139 may advance distally and disengage from the innersurface of the outer tubular member 102 creating a kink point orweakened region adjacent to the bonding region 146. Proximallyretracting the inner tubular member 110 to bring the intermediate region145 into contact with the outer tubular member 102 at contact point 148and/or bringing the proximal end portion 139 into the outer tubularmember 102 and fixing the inner tubular member 110 in this configurationmay help prevent migration of the distal holding section 108 duringnavigation of the device 100 to the desired location. Such aconfiguration may also place the inner tubular member 110 in tensionwhile the distal holding section 108 applies a compression force on theouter tubular member 102, as will be discussed in more detail below. Asdiscussed above, a locking mechanism 132 in the handle assembly 120 maybe utilized to releasably maintain the outer tubular member 102 and theinner tubular member 110 in a desired orientation.

FIG. 4 illustrates a cross-sectional view of the handle assembly 120 ofthe delivery device. As discussed above, the handle assembly 120 mayinclude a first hub portion 126 attached to the proximal end section 104of the outer tubular member 102, a second hub portion 128 attached to aproximal end section of the inner tubular member 110, and a third hubportion 130 attached to a proximal end section of a push member 116.Each of the first hub portion 126, the second hub portion 128, and thethird hub portion 130 may be slidable and rotatable relative to eachother such that the outer tubular member 102, inner tubular member 110,and push member 116 may be individually actuated.

The push member 116 may extend distally from a proximal end 117. Theproximal end 117 of the push member 116 may be positioned within oradjacent to a valve member 113. The valve member 113 may be in fluidcommunication with a lumen 154 of the push member 116. The lumen 154 mayextend from the proximal end 117 to the distal portion ix) 118 fordelivering fluids, such as, but not limited to, a contrast and/orflushing fluid to the cavity 142 of the distal holding section 108. Insome instances, the push member 116 may be coupled or affixed to thethird hub portion 130 adjacent the proximal end 117 of the push member116, although this is not required. It is contemplated that the pushmember 116 may be affixed to the third hub portion 130 at anylongitudinal location desired. In some instances, a tether (notexplicitly shown) for securing the implantable device 10 to the distalportion 118 of the push member 116 may be disposed within the lumen 154and may exit the device 100 through valve member 113, although this isnot required.

The inner tubular member 110 may extend distally from a proximal end112. The proximal end 112 of the inner tubular member 110 may bepositioned within the second hub portion 128. The inner tubular member110 may include a lumen 152 extending from the proximal end 112 to adistal end of the inner tubular member 110. The push member 116 may beslidably disposed within the lumen 152 of the inner tubular member 110.In some instances, the inner tubular member 110 may be coupled oraffixed to the second hub portion 128 adjacent the proximal end 112 ofthe push inner tubular member 110, although this is not required. It iscontemplated that the inner tubular member 110 may be affixed to thesecond hub portion 128 at any longitudinal location desired.

The outer tubular member 102 may extend distally from a proximal end105. The proximal end 105 of the outer tubular member 102 may bepositioned within the first hub portion 126. The outer tubular member102 may include a lumen 150 extending from the proximal end 105 to adistal end 103 of the outer tubular member 102. The inner tubular member110 may be slidably disposed within the lumen 150 of the outer tubularmember 102. In some instances, the outer tubular member 102 may becoupled or affixed to the first hub portion 126 adjacent the proximalend 105 of the outer tubular member 102, although this is not required.It is contemplated that the outer tubular member 102 may be affixed tothe first hub portion 126 at any longitudinal location desired.

In some instances, the first hub portion 126 may include a retainingring 158 positioned adjacent to a proximal end of the first hub portion126. In some instances, the retaining ring 158 may be rotatable about alongitudinal axis of the handle assembly 120. It is further contemplatedthat the retaining ring 158 may include locking features configured toengage with other locking features of the locking mechanism 132. In someinstances, the second hub portion 128 may include a retaining ring 164positioned adjacent to a proximal end of the second hub portion 128. Insome instances, the retaining ring 164 may be rotatable about alongitudinal axis of the handle assembly 120. It is further contemplatedthat the retaining ring 164 may include locking features configured toengage with other locking features of the locking mechanism 134.

FIG. 5 illustrates a partial perspective view of handle assembly 120with portions of the first hub portion 126 removed to more clearlyillustrate features of the first locking mechanism 132, which mayreleasably couple the first hub portion and the second hub portionand/or the outer tubular member 102 and the inner tubular member 110. Insome instances, the locking mechanism 132 may be a bayonet style lockingfeature. It is contemplated that a generally “L” shaped groove 156 maybe formed in the second hub portion 128 adjacent a distal end 129 of thesecond hub portion 128. In some instances, the retaining ring 158 mayinclude a protrusion 162 (schematically represented in FIGS. 6A-6E)extending radially inward from an inner surface of the retaining ring158. The retaining ring 158, and the first hub portion 126, may have aninner diameter generally larger than an outer diameter of the second hubportion 128 such that the second hub portion 128 can be proximallyretracted 168 and distally advanced 170 within a lumen of the first hubportion 126.

Referring additionally to FIGS. 6A-6E, when a user desires to couple theouter tubular member 102 and the inner tubular member 110, the secondhub portion 128 may be rotated 172 relative to the first hub portion 126about the longitudinal axis of the handle assembly 120 to align theprotrusion 162 with a first or vertical portion 157 of the groove 156 asshown in FIG. 6A. The use of “vertical” and “horizontal” are notintended to be limiting rather to provide relative movements ofinteracting components. In alternative embodiments, the first hubportion 126, or components thereof, may be rotated relative to thesecond hub portion 128. The second hub portion 128 may be proximallyretracted 168 to advance the protrusion 162 further into the groove 156as indicated at arrow 174. Once the protrusion 162 is positioned distalof protruding region 176, the second hub portion 128 may be rotated in afirst direction to advance the protrusion 162 along a second orhorizontal portion 159 of the groove 156 generally orthogonal to thevertical portion 157 towards a dip, recess, or serif 160 positioned atan end of the horizontal portion 159 as shown at arrow 178 in FIG. 6B. Awall 180 may provide a stopping mechanism adjacent to the serif 160.Once the protrusion 162 has engaged the stopping mechanism 180, thesecond hub portion 128 may be advanced distally 170 to secure theprotrusion 162 within the serif 160, as shown in FIG. 6C. The serif 160may help prevent accidental rotation of the retaining ring 158 and thusaccidental uncoupling of the outer tubular member 102 and the innertubular member 110.

It is contemplated that in an unbiased state or unlocked configuration,(e.g. when the outer tubular member 102 and the inner tubular member 110are not coupled via the locking mechanism 132) the distal end 129 of thesecond hub portion 128 may extend distally beyond the protrusion 162 andthe retaining ring 158. Proximally retracting the second hub portion 128(secured to the inner tubular member 110) relative to the first hubportion 126 (secured to the outer tubular member 102) to engage theprotrusion 162 and the serif 160 may place the inner tubular member 110in tension. In some instances, a tensile force in the range of about 1-3pounds-force (about 4.4-13.3 Newtons) or approximately less than 2pounds-force (approximately less than 8.9 Newtons) may be applied to theinner tubular member 110. As the inner tubular member 110 (e.g., theproximal end of the inner tubular member 110) is proximally retractedalong with the second hub portion 128, the hub portion 136 of the distalholding section 108 may apply a proximal force on the distal end of theouter tubular member 102 thus placing the outer tubular member 102 undercompression. This configuration may allow the multiple shaft deliverydevice 100 to behave like a single shaft delivery device. It iscontemplated that placing the inner tubular member 110 in tension mayaccount for a shorter path length of the outer tubular member 102 atbends in the delivery device 100. For example, as the outer tubularmember 102 curves a first side of the tube wall may have a first arcradius and a second side of the tube wall, opposite first side of thetube wall, may have a second arc radius smaller than the first arcradius. In an uncoupled configuration, the inner tubular member 110 maycontact the first side of the tube wall of the outer tubular member 102.This may place a biasing force against the outer tubular member 102 in adirection other than the desired curve. In a coupled arrangement withthe inner tubular member 110 in tension, the position of the innertubular member 110 within the lumen 150 of the outer tubular member 102may be brought closer the second side of the tube wall. This mayfacilitate steering of the device 100 to the desired location byreducing the forces applied on the outer tubular member 102.Additionally, actuation of either of the outer tubular member 102 or theinner tubular member 110 may result in the actuation of both the outertubular member 102 and the inner tubular member 110. It is furthercontemplated that when the inner tubular member 110 and the outertubular member 102 are in a coupled configuration, the distal holdingsection 108 may not move distally out of engagement with the outertubular member 102.

When a user desires to uncouple the outer tubular member 102 and theinner tubular member 110, the second hub portion 128 may be distallyadvanced 170 to disengage the protrusion 162 from the serif 160. Thesecond hub portion 128 may then be rotated 172 relative to the first hubportion 126 about the longitudinal axis of the handle assembly 120 in adirection opposite to the direction used to couple the outer tubularmember 102 and the inner tubular member 110 as indicated at arrow 182 inFIG. 6D. The second hub portion 128 may be rotated in a seconddirection, generally opposite to the first direction, to advance theprotrusion 162 along the horizontal portion 159 of the groove 156towards the vertical portion 157 as shown at arrow 182 in FIG. 6D. Awall 184 may provide a stopping mechanism adjacent to the verticalportion 157. Once the protrusion 162 has engaged the stopping mechanism184, the second hub portion 128 may be advanced distally 170 todisengage the protrusion 162 from the mating groove 156, as shown atarrow 186 in FIG. 6E. It is further contemplated that the outer surfaceof the retaining ring 158, the first hub portion 126, and/or the secondhub portion 128 may be provided with visual markings to assist the userlocking and/or unlocking the locking mechanism 132. It is furthercontemplated that in some instances, the “L” shaped groove may bepositioned on the retaining ring 158 or first hub portion 126 and theprotrusion 162 may be positioned on the second hub portion 128.Furthermore, while the first locking mechanism 132 has been described asa bayonet style locking mechanism other locking mechanisms capable ofreleasably securing the outer tubular member 102 and the inner tubularmember 110 are contemplated.

For example, the locking mechanism 132 may be formed in a similar mannerto a quick connect locking mechanism commonly used in plumbingapplications. A quick connect locking mechanism may utilize an o-ringand a compression fit to maintain a fluid tight seal. A rotating lockingring may maintain the quick connect locking mechanism in a lockedconfiguration. In other embodiments, the locking mechanism 132 mayinclude a threaded engagement similar to the threaded engagementdescribed above with respect to FIG. 3A. For example, the retaining ring158 or other portion of the first hub portion 126 may include a firstthreaded region and the second hub portion 128 may include a secondthreaded region configured to mate with and/or threadably engage thethreaded region on the retaining ring 158 or other portion of the firsthub portion 126. Thus rotation of the retaining ring 158 and/or otherportion of the first hub portion 126 relative to the second hub portion128 may place the inner tubular member 110 in tension while placing theouter tubular member 102 in compression. In yet other embodiments, thelocking mechanism 132 may include a snap lock, a tongue and groove typelock, a mating detent and groove or other features configured to engagea corresponding feature on the retaining ring 158 and/or second hubportion 128 similar to the coupling arrangement described above withrespect to FIG. 3B.

FIG. 7 illustrates another partial perspective view of handle assembly120 with portions of the second hub portion 128 removed to more clearlyillustrate features of the second locking mechanism 134, which may beused to releasably couple the inner tubular member 110 and the pushmember 116. In some instances, the locking mechanism 134 may be abayonet style locking feature. It is contemplated that a generally “L”shaped groove 166 may be formed in the third hub portion 130 adjacent adistal end 131 of the third hub portion 130. In some instances, theretaining ring 164 (not explicitly shown in FIG. 7) may include aprotrusion, which may be similar in form and function to the protrusion162 described with respect to FIGS. 5 and 6A-6E, extending radiallyinward from an inner surface of the retaining ring 164. The retainingring 164, and the second hub portion 128, may have an inner diametergenerally larger than an outer diameter of the third hub portion 130such that the third hub portion 130 can be proximally retracted 168 anddistally advanced 170 within a lumen of the second hub portion 128. Itis contemplated that the second locking mechanism 134 may function in asimilar manner to the first locking mechanism 132 described above.

When a user desires to couple the inner tubular member 110 and the pushmember 116, the third hub portion 130 may be rotated 172 relative to thesecond hub portion 128 in a first direction about the longitudinal axisof the handle assembly 120 to align the protrusion with a first orvertical portion 165 of the groove 166. The use of “vertical” and“horizontal” are not intended to be limiting rather to provide relativemovements of interacting components. In alternative embodiments, thesecond hub portion 128, or components thereof, may be rotated relativeto the third hub portion 128. The third hub portion 130 may beproximally retracted 168 to advance the protrusion further into thegroove 166. Once the protrusion is positioned distal of protrudingregion 171, the third hub portion 130 may be rotated to advance theprotrusion along a second or horizontal portion 167 of the groove 166generally orthogonal to the vertical portion 165 towards a dip or serif169 positioned at an end of the horizontal portion 167. A wall 173 mayprovide a stopping mechanism adjacent to the serif 169. Once theprotrusion has engaged the stopping mechanism 173, the third hub portion130 may be advanced distally 170 to secure the protrusion within theserif 169. The serif 169 may help prevent accidental rotation of theretaining ring 164 and thus accidental uncoupling of the inner tubularmember 110 and the push member 116.

It is contemplated that in an unbiased state or unlocked configuration,(e.g. when the inner tubular member 110 and the push member 116 are notcoupled via the locking mechanism 134) the distal end 131 of the thirdhub portion 130 may extend distally beyond the protrusion and theretaining ring 164. Proximally retracting the third hub portion 130(secured to the push member 116) relative to the second hub portion 128(secured to the inner tubular member 110) to engage the protrusion andthe serif 169 may place the push member 116 in tension. It iscontemplated that placing the push member 116 in tension may account fora shorter path length at bends in the delivery device 100.

When a user desires to uncouple the inner tubular member 110 and thepush member 116, the third hub portion 130 may be distally advanced 170to disengage the protrusion from the serif 169. The third hub portion130 may then be rotated 172 relative to the second hub portion 128 in asecond direction, generally opposite the first direction, about thelongitudinal axis of the handle assembly 120. The third hub portion 130may be rotated to advance the protrusion along the horizontal portion167 of the groove 166 towards the vertical portion 165. A wall 175 mayprovide a stopping mechanism adjacent to the vertical portion 165. Oncethe protrusion has engaged the stopping mechanism 175, the third hubportion 130 may be advanced distally 170 to disengage the protrusionfrom the mating groove 166. It is further contemplated that the outersurface of the retaining ring 164, second hub portion 128, and/or thethird hub portion 130 may be provided with visual markings to assist theuser locking and/or unlocking the locking mechanism 134. It is furthercontemplated that in some instances, the “L” shaped groove may bepositioned on the retaining ring 164 or second hub portion 128 and theprotrusion may be positioned on the third hub portion 130. Furthermore,while the second locking mechanism 134 has been described as a bayonetstyle locking mechanism other locking mechanisms capable of releasablysecuring the inner tubular member 110 and the push member 116 arecontemplated.

For example, the locking mechanism 134 may be formed in a similar mannerto a quick connect locking mechanism commonly used in plumbingapplications. A quick connect locking mechanism may utilize an o-ringand a compression fit to maintain a fluid tight seal. A rotating lockingring may maintain the quick connect locking mechanism in a lockedconfiguration. In other embodiments, the locking mechanism 134 mayinclude a threaded engagement similar to the threaded engagementdescribed above with respect to FIG. 3A. For example, the retaining ring164 or other portion of the second hub portion 128 may include a firstthreaded region and the third hub portion 130 may include a secondthreaded region configured to mate with and/or threadably engage thethreaded region on the retaining ring 164 or other portion of the secondhub portion 128. Thus rotation of the retaining ring 164 and/or otherportion of the second hub portion 128 relative to the third hub portion130 may place the push member 116 in tension. In yet other embodiments,the locking mechanism 134 may include a snap lock, a tongue and groovetype lock, a mating detent and groove or other features configured toengage a corresponding feature on the retaining ring 164 and/or thirdhub portion 130 similar to the coupling arrangement described above withrespect to FIG. 3B.

The materials that can be used for the various components of thedelivery devices, such as delivery device 100 (and/or other deliverystructures disclosed herein) and the various members disclosed hereinmay include those commonly associated with medical devices. Forsimplicity purposes, the following discussion makes reference thedelivery device 100 and components of thereof. However, this is notintended to limit the devices and methods described herein, as thediscussion may be applied to other similar delivery systems and/orcomponents of delivery systems or devices disclosed herein.

The delivery device 100 and/or other components of delivery system maybe made from a metal, metal alloy, polymer (some examples of which aredisclosed below), a metal-polymer composite, ceramics, combinationsthereof, and the like, or other suitable material. Some examples ofsuitable polymers may include polytetrafluoroethylene (PTFE), ethylenetetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP),polyoxymethylene (POM, for example, DELRIN® available from DuPont),polyether block ester, polyurethane (for example, Polyurethane 85A),polypropylene (PP), polyvinylchloride (PVC), polyether-ester (forexample, ARNITEL® available from DSM Engineering Plastics), ether orester based copolymers (for example, butylene/poly(alkylene ether)phthalate and/or other polyester elastomers such as HYTREL® availablefrom DuPont), polyamide (for example, DURETHAN® available from Bayer orCRISTAMID® available from Elf Atochem), elastomeric polyamides, blockpolyamide/ethers, polyether block amide (PEBA, for example availableunder the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA),silicones, polyethylene (PE), Marlex high-density polyethylene, Marlexlow-density polyethylene, linear low density polyethylene (for exampleREXELL®), polyester, polybutylene terephthalate (PBT), polyethyleneterephthalate (PET), polytrimethylene terephthalate, polyethylenenaphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI),polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide(PPO), poly paraphenylene terephthalamide (for example, KEVLAR®),polysulfone, nylon, nylon-12 (such as GRILAMID® available from EMSAmerican Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinylalcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC),poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS50A), polycarbonates, ionomers, biocompatible polymers, other suitablematerials, or mixtures, combinations, copolymers thereof, polymer/metalcomposites, and the like. In some embodiments the polymer can be blendedwith a liquid crystal polymer (LCP). For example, the mixture cancontain up to about 6 percent LCP.

Some examples of suitable metals and metal alloys include stainlesssteel, such as 304V, 304L, and 316LV stainless steel; mild steel;nickel-titanium alloy such as linear-elastic and/or super-elasticnitinol; other nickel alloys such as nickel-chromium-molybdenum alloys(e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY®C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys,and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL®400, NICKELVAC® 400, NICORROS® 400, and the like),nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such asMP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 suchas HASTELLOY® ALLOY B2®), other nickel-chromium alloys, othernickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-ironalloys, other nickel-copper alloys, other nickel-tungsten or tungstenalloys, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenumalloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like);platinum enriched stainless steel; titanium; combinations thereof; andthe like; or any other suitable material.

As alluded to herein, within the family of commercially availablenickel-titanium or nitinol alloys, is a category designated “linearelastic” or “non-super-elastic” which, although may be similar inchemistry to conventional shape memory and super elastic varieties, mayexhibit distinct and useful mechanical properties. Linear elastic and/ornon-super-elastic nitinol may be distinguished from super elasticnitinol in that the linear elastic and/or non-super-elastic nitinol doesnot display a substantial “superelastic plateau” or “flag region” in itsstress/strain curve like super elastic nitinol does. Instead, in thelinear elastic and/or non-super-elastic nitinol, as recoverable strainincreases, the stress continues to increase in a substantially linear,or a somewhat, but not necessarily entirely linear relationship untilplastic deformation begins or at least in a relationship that is morelinear that the super elastic plateau and/or flag region that may beseen with super elastic nitinol. Thus, for the purposes of thisdisclosure linear elastic and/or non-super-elastic nitinol may also betermed “substantially” linear elastic and/or non-super-elastic nitinol.In some cases, linear elastic and/or non-super-elastic nitinol may alsobe distinguishable from super elastic nitinol in that linear elasticand/or non-super-elastic nitinol may accept up to about 2-5% strainwhile remaining substantially elastic (e.g., before plasticallydeforming) whereas super elastic nitinol may accept up to about 8%strain before plastically deforming. Both of these materials can bedistinguished from other linear elastic materials such as stainlesssteel (that can also can be distinguished based on its composition),which may accept only about 0.2 to 0.44 percent strain beforeplastically deforming.

In some embodiments, the linear elastic and/or non-super-elasticnickel-titanium alloy is an alloy that does not show anymartensite/austenite phase changes that are detectable by differentialscanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA)analysis over a large temperature range. For example, in someembodiments, there may be no martensite/austenite phase changesdetectable by DSC and DMTA analysis in the range of about −60 degreesCelsius (° C.) to about 120° C. in the linear elastic and/ornon-super-elastic nickel-titanium alloy. The mechanical bendingproperties of such material may therefore be generally inert to theeffect of temperature over this very broad range of temperature. In someembodiments, the mechanical bending properties of the linear elasticand/or non-super-elastic nickel-titanium alloy at ambient or roomtemperature are substantially the same as the mechanical properties atbody temperature, for example, in that they do not display asuper-elastic plateau and/or flag region. In other words, across a broadtemperature range, the linear elastic and/or non-super-elasticnickel-titanium alloy maintains its linear elastic and/ornon-super-elastic characteristics and/or properties.

In some embodiments, the linear elastic and/or non-super-elasticnickel-titanium alloy may be in the range of about 50 to about 60 weightpercent nickel, with the remainder being essentially titanium. In someembodiments, the composition is in the range of about 54 to about 57weight percent nickel. One example of a suitable nickel-titanium alloyis FHP-NT alloy commercially available from Furukawa Techno Material Co.of Kanagawa, Japan. Some examples of nickel titanium alloys aredisclosed in U.S. Pat. Nos. 5,238,004 and 6,508,803, which areincorporated herein by reference. Other suitable materials may includeULTANIUM™ (available from Neo-Metrics) and GUM METAL™ (available fromToyota). In some other embodiments, a superelastic alloy, for example asuperelastic nitinol can be used to achieve desired properties.

In at least some embodiments, portions or all of the delivery device 100and/or other components of delivery system may be doped with, made of,or otherwise include a radiopaque material. Radiopaque materials areunderstood to be materials capable of producing a relatively brightimage on a fluoroscopy screen or another imaging technique during amedical procedure. This relatively bright image aids the user of thedelivery device 100 in determining its location. Some examples ofradiopaque materials can include, but are not limited to, gold,platinum, palladium, tantalum, tungsten alloy, polymer material loadedwith a radiopaque filler, and the like. Additionally, other radiopaquemarker bands and/or coils may also be incorporated into the design ofthe delivery device 100 to achieve the same result.

In some embodiments, a degree of Magnetic Resonance Imaging (Mill)compatibility is imparted into the delivery device 100. For example,delivery device 100 or portions or components thereof, may be made of amaterial that does not substantially distort the image and createsubstantial artifacts (i.e., gaps in the image). Certain ferromagneticmaterials, for example, may not be suitable because they may createartifacts in an Mill image. The delivery device 100, or portionsthereof, may also include and/or be made from a material that the Millmachine can image. Some materials that exhibit these characteristicsinclude, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g.,UNS: R30003 such as ELGILOY®, PHYNOX®, and the like),nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such asMP35-N® and the like), nitinol, and the like, and others.

It should be understood that this disclosure is, in many respects, onlyillustrative. Changes may be made in details, particularly in matters ofshape, size, and arrangement of steps without exceeding the scope of thedisclosure. This may include, to the extent that it is appropriate, theuse of any of the features of one example embodiment being used in otherembodiments. The invention's scope is, of course, defined in thelanguage in which the appended claims are expressed.

What is claimed is:
 1. A delivery device for delivering an implantableleadless pacing device, the delivery device comprising: an outer tubularmember including a lumen extending from a proximal end to a distal endthereof; an inner tubular member including a lumen extending from aproximal end to a distal end thereof, the inner tubular member slidablydisposed within the lumen of the outer tubular member; a distal holdingsection secured to and extending distally of a distal end of the innertubular member, the distal holding section defining a cavity therein forreceiving an implantable leadless pacing device; a push member having aproximal end and a distal end, the push member slidably disposed withinthe lumen of the inner tubular member; a handle assembly including atleast a first hub portion affixed adjacent to the proximal end of theouter tubular member, a second hub portion extending proximal of aproximal end of the first hub portion, the second hub portion affixedadjacent to the proximal end of the inner tubular member, and a thirdhub portion extending proximal of a proximal end of the second hubportion, the third hub portion affixed adjacent to the proximal end ofthe push member, the first hub portion, the second hub portion, and thethird hub portion each selectively longitudinally movable relative toeach other along a longitudinal axis of the handle assembly.
 2. Thedelivery device of claim 1, further comprising: a first lockingmechanism configured to releasably lock the first hub portion to thesecond hub portion, the first locking mechanism having a locked positionand an unlocked position, wherein in the unlocked position of the firstlocking mechanism the first hub portion is longitudinally movablerelative to the second hub portion.
 3. The delivery device of claim 2,further comprising: a second locking mechanism configured to releasablylock the second hub portion to the third hub portion, the second lockingmechanism having a locked position and an unlocked position, wherein inthe unlocked position of the second locking mechanism the second hubportion is longitudinally movable relative to the third hub portion. 4.The delivery device of claim 2, wherein in the locked position of thefirst locking mechanism the inner tubular member is held in tension andthe outer tubular member is held in compression.
 5. The delivery deviceof claim 2, wherein the first locking mechanism includes a rotatableretaining ring rotatable about the longitudinal axis of the handleassembly.
 6. The delivery device of claim 5, wherein the rotatableretaining ring is positioned at a proximal end of the first hub portion.7. The delivery device of claim 6, wherein the second hub portionextends through the rotatable retaining ring.
 8. The delivery device ofclaim 2, wherein in the locked position, the inner tubular member isheld in tension, causing a hub section of the distal holding section tocontact and apply a proximal force to the distal end of the outertubular member.
 9. The delivery device of claim 8, wherein in the lockedposition, the outer tubular member is held in compression by theproximal force.
 10. The delivery device of claim 1, further comprising:a locking mechanism configured to releasably lock the second hub portionto the third hub portion, the locking mechanism having a locked positionand an unlocked position, wherein in the unlocked position of thelocking mechanism the second hub portion is longitudinally movablerelative to the third hub portion.
 11. The delivery device of claim 1,wherein a distal portion of the second hub portion slidably extends intothe first hub portion.
 12. The delivery device of claim 1, wherein adistal portion of the third hub portion slidably extends into the secondhub portion.
 13. The delivery device of claim 1, wherein the third hubportion includes a valve member in fluid communication with a lumenextending through the push member.
 14. A delivery device for deliveringan implantable leadless pacing device, the delivery device comprising:an outer tubular member including a lumen extending from a proximal endto a distal end thereof; an inner tubular member including a lumenextending from a proximal end to a distal end thereof, the inner tubularmember slidably disposed within the lumen of the outer tubular member; adistal holding section secured to and extending distally of a distal endof the inner tubular member, the distal holding section defining acavity therein for receiving an implantable leadless pacing device; apush member having a proximal end and a distal end, the push memberslidably disposed within the lumen of the inner tubular member; a handleassembly including at least a first hub portion affixed adjacent to theproximal end of the outer tubular member, a second hub portion extendingproximal of a proximal end of the first hub portion, the second hubportion affixed adjacent to the proximal end of the inner tubularmember, and a third hub portion extending proximal of a proximal end ofthe second hub portion, the third hub portion affixed adjacent to theproximal end of the push member, the first hub portion, the second hubportion, and the third hub portion each selectively longitudinallymovable relative to each other along a longitudinal axis of the handleassembly; wherein a distal portion of the second hub portion slidablyextends into the first hub portion with a proximal portion of the secondhub portion extending proximal of a proximal end of the first hubportion.
 15. The delivery device of claim 14, wherein a distal portionof the third hub portion extends distal of a proximal end of the secondhub portion.
 16. The delivery device of claim 15, wherein the distalportion of the third hub portion slidably extends into the second hubportion.
 17. The delivery device of claim 15, wherein the third hubportion extends proximal of the proximal end of the second hub portion.18. The delivery device of claim 14, further comprising: a first lockingmechanism configured to releasably lock the first hub portion to thesecond hub portion, the first locking mechanism having a locked positionand an unlocked position, wherein in the unlocked position of the firstlocking mechanism the first hub portion is longitudinally movablerelative to the second hub portion.
 19. The delivery device of claim 18,further comprising: a second locking mechanism configured to releasablylock the second hub portion to the third hub portion, the second lockingmechanism having a locked position and an unlocked position, wherein inthe unlocked position of the second locking mechanism the second hubportion is longitudinally movable relative to the third hub portion. 20.The delivery device of claim 18, wherein in the locked position of thefirst locking mechanism the inner tubular member is held in tension andthe outer tubular member is held in compression.